Overview
The healthcare industry is changing dramatically and managed care has become the driving force in healthcare delivery systems. The pharmaceutical industry which in the past found safety and efficacy to be the chief criteria in marketing their products, is now encountering the additional requirements that their products be cost effective and improve the quality of care.
Both the pharmaceutical and managed care segments of the industry are heavily involved in clinical research and both are aggressively outsourcing research projects. The market for research services will expand as employers begin the process of researching the value of health care services in light of escalating premiums. Smith Barney estimates that the world wide market for clinical research is $3 billion.
Covalent's pharmaceutical industry customers, which have always had strong internal clinical research organizations, are outsourcing more as part of a continuing effort to control costs and growth of internal staff. Managed care, which in most cases has not had strong internal research organizations, is now being forced to evaluate the efficiency of their healthcare guidelines, and patient education and compliance programs to control their rising costs. Employers are also beginning to determine how to gather data that justifies the cost of rising healthcare premiums.
Covalent is strategically positioned with services, staff, and technological tools to meet the growing needs of the rapidly changing healthcare industry.
Covalent's Healthcare Industry Services
Covalent is a unique total research management organization that differentiates itself in two ways which assure that pharmaceutical interventions get to the customer, either the patient or managed care, faster. First the company has demonstrated ability to accelerate the drug development process. Second, it can integrate its unique information technologies into health management products that improve patient compliance and well-being. Patient compliance with prescribed drug regimens is of great importance to both pharmaceutical companies, where increased compliance translates into increase sales, and managed care organizations where improved patient compliance reduces the demand for expensive resources.
Covalent's strength is designing, coordinating and monitoring clinical trials during the drug development process. Covalent has successfully positioned itself to conduct these crucial trials in both the traditional clinic and hospital settings, and in managed care, where the pharmaceutical industry is marketing their products and shifting their research efforts. Covalent has worked with over 40 managed care organizations, strengthening its ability deliver its clinical research services to the pharmaceutical industry. Covalent also utilizes its core expertise of clinical trials management, to provide high-quality, medical outcomes and clinical research to its customer base. To aid its pharmaceutical and managed care customers in clinical trials and outcomes research projects, the company is developing a state-of-the-art interactive voice recognition system: Virtual HouseCall (tm), an automated system for collecting and reporting subjective patient information. Educational components are also being developed for Virtual HouseCall (tm). Virtual Housecall's educational components are focused on influencing patient behaviors crucial to patient compliance with prescription drug regimens and self-management of chronic diseases.
Clinical Trials
Covalent has a proven team of individuals with experience in the pharmaceutical, biotech and managed care industries that can support the needs of the most rigorous clinical trial or medical outcomes studies. The Company has assembled an extensive network of clinical investigators, managed care organizations, and clinical research specialists, which it uses to coordinate and conduct clinical research. Covalent's clinical monitors are strategically located throughout the country to reduce the cost of travel to clinical or managed care sites. Covalent's full range of clinical trial services include:
-Project Coordination
-Regulatory Document Processing
-Monitoring Services
-Quality Control Review
-Data Management
-Biostatistics
-Regulatory Affairs Management
-Quality Assurance & Compliance
In addition Covalent offers the following services on a modular basis.
Data Management
Covalent has automated the data management process associated with clinical trials management through its use and customization of the industry standard software from BBN Software Products' Clintrial (tm). Clintrial protocols are used to assist in the collection, validations, and reporting of clinical results for the company's clients, the Food and Drug Administration (FDA), or other regulatory agencies. Covalent's data management professionals provide the following services:
-Case Report Form Review and Tracking
-Data Entry
-Medical Writing
-Integrated Clinical/Statistical Reports
-Manuscripts for Publication
Biostatistics
Covalent provides complete clinical statistics support. The company's Biostatisticians have extensive pharmaceutical/medical industry experience. Covalent's biostatistical services include:
-Clinical Trials Design
-Preparing Statistical Analysis Plans
-Representing Client and the FDA
-Creating Statistical Reports
Regulatory Affairs Management
Covalent's regulatory group provides liaison services between our clients and regulatory agencies, in the preparation, review, and submission of Investigational New Drug (IND), New Drug Application (NDA), 510k, and PLA documents.
Quality Assurance & Compliance
Covalent provides field inspections that include investigator audits, pre-submission audits, protocol compliance audits, Good Clinical Practice audits, and staff training.
Outcomes Research and Management
Cost containment has become the focus of the major payers of the nation's health care bills. Determining the value of health care through assessment of the appropriateness, effectiveness, and costs of services is the role of outcomes research. Covalent provides retrospective database studies, therapeutic end-point determinations, cost effectiveness studies, drug utilization reviews, and health status survey development. In addition Covalent can provide patient drug compliance programs, patient education programs, and cost containment studies.
Wellness Measures (TM)
As employers search for ways to reduce the high cost of providing medical benefits to their employees, health promotion programs have come to the forefront. Wellness Measures, a division of Covalent, provides a comprehensive set of services which improve the health of individuals, insure proper utilization of health care services, reduce health care costs, and improve morale and mental acuity. Wellness Measures' assessment services allows their clients to make informed decisions that benefit their companies, employees, and their families.
Virtual HouseCall(TM)
Developed by Covalent, Virtual HouseCall (VHC) is an interactive voice recognition system that excels in the type of data collection and analysis required by healthcare industry segment focused on disease management. Disease management is a comprehensive, integrated approach to care and reimbursement with a goal of promoting maximum healthcare provider efficiency and effectiveness. Data collection becomes the key to continuing assessment of disease management programs.
VHC is a telephone-based service that has been designed to reach millions of patients in a personalized and supportive manner. VHC automates the administration of subjective quality of life surveys and psychosocial assessments, provides patient access to disease specific educational and resource libraries, and facilitates the publication of personalized reports through on-demand printing services and faxes to healthcare providers and patients.
VHC will initially focus on four disease states that accounts for 70% of managed care's patient expenditures. Virtually all managed care organizations and many pharmaceutical companies are developing disease management programs in the areas of asthma, diabetes, hypertension, and depression. VHC can play an important role in any disease management program, its content is modular and customizable, and the computer platform and telephony systems are highly scaleable.
VHC as a research and patient education service will be sold on a transaction basis. This allows the greatest flexibility for Covalent's customers. Surveys could be administered once, while VHC-based patient tracking, assessment, education could be provided as often as monthly. Per transaction costs are calculated by type of service, length and frequency of interaction, and the number of contracted patients. |
